An open label parallel design randomized control trial of type 2 diabetes management with two-meals a day and exercise against the conventional multi-meal and exercise approach for effect on HbA1c and anti-diabetic medication in six months in newly detected diabetic subjects in a tertiary care Institute in Maharashtra.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
Type 2 Diabetes is the rapidly growing non communicable disease in India, with preponement of age of commencement and early organ damage. The world needs ways to prevent Type 2 Diabetes epidemic and rollback of the disease. However, the rising prevalence of Type 2 Diabetes is evidence that both lifestyle and clinical management are facing challenges.
Conventional management of T2DM banks on small frequent meals, moderate exercise, and anti-diabetic medication (ADM). Many patients are now following a 2-meal a day frequency and moderate exercise (2OMEX) lifestyle with medication adjustments due to a popular campaign in Maharashtra, with a reported decline in HbA1c and even remission of Type 2 Diabetes. The recommendations strongly suggest that newly diagnosed diabetic subjects should receive a fair trial with lifestyle modification before initiating oral hypoglycaemic medication. Currently, various lifestyle modifications are popular including vegan diets, small diets for calorie restriction, intermittent fasting, and all with moderate daily/ weekly /5 days workouts.
The present study aims to test this hypothesis of Type 2 Diabetes control and remission in 2OMEX and conventional management arm, the main difference being frequency of meals (2 meals only or more than 2 meals as daily routine), while moderate exercise of 45 minutes (4.5 km walk) being common to both arms. We want to do this as an open label randomized clinical study, in a tertiary institute setting, OPD subjects detected recently with uncomplicated T2D with HbA1c between 7-10 gm% and on, none or two or less oral anti-diabetic medication molecules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Recently detected Type 2 Diabetic patients willing to adopt change to two-meal and currently doing/willing to do mandatory exercise and without Nephropathy,cardiac involvement or neuropathy,not on insulin, HbA1c < 10gm%, yet to be started or on 2 or less anti-diabetic molecules.
排除标准
- •Patients with Nephropathy,cardiac involvement or neuropathy Patients on insulin therapy, HbA1c > 10gm%, Patients on more than 2 anti-diabetic molecules.
结局指标
主要结局
Change in HbA1c
时间窗: 1. At enrolment | 2. At 60 days | 3. At 120 days | 4. AT 180 days
次要结局
- Change in anti-diabetic medications(1. At enrolment)
- Change in BMI and Waist circumference(1. At enrolment)
